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HQ 951204

June 23, 1992

CLA-2 CO:R:C:F 951204 ALS


TARIFF NO.: 4015.11.0000

District Director of Customs
1 East Bay Street
Savannah, Georgia 31401

RE: Request for Further Review of Protest 1704-91-100301, dated November 7, 1991, Concerning Ambidextrous Disposable Latex Rubber Examination Gloves

Dear Mr. Richter:

This ruling is on a protest that was filed against your decisions of August 9, 1991, in the liquidations of several entries covering the referenced articles.


The articles under consideration are disposable unsterilized latex examination gloves produced in Malaysia which are approximately 9-1/2 inches in length. They are ambidextrous and are produced in three sizes: small, medium and large. They are lightly powdered to facilitate their placement on a user's hands. They are packaged in dispenser boxes that hold one hundred gloves.


What is the classification of ambidextrous natural latex disposable rubber examination gloves?


Classification of merchandise under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) is governed by the General Rules of Interpretation (GRI's) taken in order.

GRI 1 provides that the classification is determined first in accordance with the terms of the heading and any relative section and chapter notes. If GRI 1 fails to classify the goods and if the heading and legal notes do not otherwise require, the remaining GRI's are applied, taken in order.

The articles under consideration were classified by Customs as surgical and medical gloves under subheading 4015.11.0000, HTSUSA. The protestant states that the gloves are not medical gloves and that they should be classified under subheading 4015.19.1010, HTSUSA, as other gloves. Counsel states that subheading 4015.11, HTSUSA, does not apply to non-sterile exam gloves which are used in a more generalized healthcare situation or elsewhere. Counsel states that "medical or surgical gloves utilized for body-intrusive procedure must be sterilized and are usually procedure specific...." According to counsel such gloves are only considered medical if they are "...manufactured as and used primarily by physicians while performing medical tasks and used primarily for the protection of the patient. Use in a general healthcare environment is insufficient for classification under this provision."

In considering this matter we consulted the Explanatory Notes to the Harmonized System which represent the opinion of the international classification experts, but are not legally binding. The subheading explanatory note to subheading 4015.11 thereof described surgical gloves as "...thin, highly tear-resistant articles manufactured by immersion, of a kind worn by surgeons. They are generally presented in sterile packs." No provision is presented therein as to patient examination gloves.

We also consulted the regulations of the Food and Drug Administration. In this regard, we were unable to confirm that there is a regulation of that agency which requires the labelling of gloves for industrial use. Several FDA sources informally advised us that that agency would not be interested in latex gloves being brought in for non-medical purposes. We also consulted Part 800 of the FDA Regulations (21 CFR Part 800) regarding patient examination and surgeons' gloves; adulteration. These regulations, written in light of the prevalence of human immunodeficiency virus (HIV) infections and applicable to all medical and surgical gloves, define adulteration of the referenced gloves and establish the sample plans and test method to be used to determine if the gloves are adulterated.

Section 880.6250, FDA Regulations (21 CFR 880.6250) defines a patient examination glove as "...a disposable device intended for medical purposes that is worn on the examiner's hand or - 3 -
finger to prevent contamination between patient and examiner." Section 880.4460, FDA Regulations (21 CFR 880.4460) defines a surgeon's glove as "...a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination." While there is no FDA regulatory requirement that these gloves be sterile, FDA guidelines do provide that gloves utilized during operating procedures meet certain sterility requirements. The aforementioned FDA sources advised us that appropriate sterility requirements may be met at or subsequent to importation if the gloves are identified as medical or surgical gloves. The sterility requirements must be met before the gloves are made available to the end-user.

In discussions with both FDA sources and a practicing physician we confirmed that only a small category of these gloves, i.e., surgeon's gloves, utilized when there is an open wound, such as during an operation, must be sterile. Examination gloves, even those utilized for rectal and vaginal examinations, are not normally sterile. These gloves are packaged in dispenser boxes in the same manner as the protestant's ambidextrous gloves.

We were unable to find any difference between the gloves which are the subject of this protest and those commonly seen in a physician's office.

The above-noted physician advised us that a sterile environment is only a concern when there is an open wound where blood may be present. He noted that non-sterile examination gloves which protect the physician from a disease and assure that a disease will not be transmitted from one patient to another via the physician are satisfactory for this purpose.

In further considering the documents of record, we noted that the supplier's invoice to the protestant indicates that the gloves:

(1) Are listed with the FDA on Product Listing Document #444401
(2) Conform to specification G109-887-07 dated: 15-08-1990 (3) Have the FDA's 510(K) letter, K891255 of "SUBSTANTIAL EQUIVALENCE" finalized and dated April 13, 1989

The aforementioned FDA sources advised us that these documents relate only to various aspects of medical glove approval. They noted that they would not be interested in the - 4 -
gloves unless such gloves were declared to be medical gloves. The presentation of these shipments to FDA for clearance at the time of importation on FDA Form 702, further confirms that these gloves were considered medical gloves at the time of importation.

While neither the FDA Regulations nor FDA actions are binding on the Customs Service and are referenced for information purposes only, we note that those regulations and actions do not provide any basis for distinguishing medical gloves from non-medical gloves. We also noted that protestant has not provided any objective basis for distinguishing its product from those which are labelled medical gloves. Other than statements, made in the protest that the gloves would be used for non-medical purposes, which conflict with previously noted documentary information, there does not appear to be any basis for distinguishing these gloves from those described as medical gloves.


Ambidextrous disposable latex examination gloves, the product of Malaysia, are classifiable under subheading 4015.11.0000, HTSUSA, and are subject to a general rate of duty of 3.7 percent ad valorem.

Since the rate of duty under the classification indicated above is the same as the liquidated rate, you are instructed to deny the protest in full. A copy of this decision should be attached to Customs Form 19 and provided to the protestant a part of the notice of action on the protest.


John Durant, Director
Commercial Rulings Division

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